drugset / Trial / NCT06569524
Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
Phase 2
Recruiting
120 enrolled
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Timeline
- Start
- 2023-09-14
- Primary completion
- 2026-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TQA2225/AP025 | Protein / enzyme biologic | 25 mg | Subcutaneous |
| Subject | TQA2225/AP025 | Protein / enzyme biologic | 50 mg | Subcutaneous |